JSP191 (briquilimab) in Subjects with LR-MDS

Phase 1

Terminated

• Conditions: Lower-risk Myelodysplastic Syndrome
• Interventions: Drug: JSP191

• Registration Number: NCT05903274
• Lead Sponsor: Jasper Therapeutics, Inc.

Brief Summary

A Phase 1 study in subjects with LR-MDS to assess the safety and tolerability of JSP191 as a second-line therapy.

Detailed Description

An open-label, single-arm, dose-escalation study designed to determine the potential safety, efficacy, maximum tolerated dose (MTD) or optimal biologic dose (OBD), and recommended phase 2 dose (RP2D) of JSP191 (briquilimab) monotherapy for LR-MDS subjects with documented cytopenia (red blood cell-transfusion dependent, thrombocytopenia, and/or neutropenia).

Study Timeline

• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-05
• Study First Posted: 2023-06-15
• Study Start: 2023-06-19
• Primary Completion: 2024-10-21
• Study Completion: 2024-10-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Age ≥ 18 years
• MDS with IPSS-R very low, low, or intermediate risk features
• Symptomatic cytopenias
• Women of childbearing potential (WOCBP) must agree to use an oral or implanted contraceptive, a double-barrier method of birth control, or an intrauterine device upon enrollment and through 3 months after receiving the last dose of JSP191
• Women not of childbearing potential must be post-menopausal (no menstrual period for a minimum of 12 months) or surgically sterilized and have a negative serum pregnancy test upon study entry
• Male subjects must be surgically sterile or willing to use contraception upon enrollment and through 3 months after receiving the last dose of JSP191
• Must be willing and able to provide informed consent

Exclusion Criteria

• Anemia secondary to iron deficiency, vitamin B12 deficiency, or folate deficiency
• Prior allogeneic or autologous stem cell transplant
• Known history of human immunodeficiency virus (HIV) (no laboratory testing is required), or active infection with hepatitis B or hepatitis C
• Pregnant women or women who are nursing and do not wish to discontinue breastfeeding
• Any other medical condition that, in the opinion of the Investigator, could pose a significant safety risk to the subject or jeopardize the integrity of the study
• Subjects who, in the opinion of the Investigator, may not be able to comply with the requirements of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
JSP191	JSP191	This study will explore up to 5 ascending dose levels (Cohorts 1, 2, 3, 4, and 5) and subjects will receive JSP191 on Day 1 on each 8-week cycle for 4 consecutive cycles.

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of JSP191	32 weeks	Assessed by the frequency, duration, and severity of adverse events

Trial Locations

Locations (2)

Memorial Healthcare System; 🇺🇸 Hollywood, Florida, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States